Case Study 1

Quality Context provides external QP resource to a small, generic pharmaceutical company whose main business is the importation of solid-dose products from outside the European Union. This involves close focus upon legal and regulatory requirements for outsourcing and importation as well as supply chain assurance.

Quality Context conducts QP certification on an as-required basis to support the company's main QP when times are busy or when the main QP must be away from the office.

Quality Context also assists with the drafting of internal quality SOPs and review of quality documentation such as Product Quality Reviews. Quality Context visits the site regularly to keep up to date with the people and processes, allowing us to conduct a large proportion of the work required from our base in Sheffield.

Case Study 2

Quality Context also utilise their experience and knowledge of IMPs to support a small, virtual pharmaceutical company scaling up their development products, supplying IMP to clinical trials and maintaining their Quality Management Systems surrounding clinical trial and commercial products.